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Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia (DE-PLAN-CAT)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Prevention, Diabetes mellitus, Lifestyle changes, Cardiovascular risk, Cost-effectiveness

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • High risk (> or equal 14 points in FINDRISC score)
  • PTOG with IFG/ITG or both
  • Able to sign informed consent

Exclusion Criteria:

  • Type 2 diabetes in screening
  • Low risk (< 14 points in FINDRISC)
  • Terminal diseases

Sites / Locations

  • IDIAP Jordi Gol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle counseling

Usual health care

Arm Description

Complete lifestyle counseling including Individual intervention, OR Group intervention

Usual health care, including self-administered information by leaflets

Outcomes

Primary Outcome Measures

Incident cases of type 2 diabetes
New cases of type 2 diabetes in subjects with high risk during the duration of the study

Secondary Outcome Measures

Evaluation of quality of life
Quality of life in the 15-D questionnaire
Cost-effectiveness
Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes

Full Information

First Posted
January 24, 2012
Last Updated
January 26, 2012
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT01519505
Brief Title
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia
Acronym
DE-PLAN-CAT
Official Title
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III, Department of Health, Generalitat de Catalunya

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Public health strategy on type2 diabetes prevention in primary health care. European coordinated project (DE-PLAN) adapted to Catalonia (DE-PLAN-CAT). Two-step multicentre cohort study: cross-over period (screening) plus a follow-up period (preventive intervention): 12 centres, 7 working-groups, 42 units, 106 professionals). Interventions: Randomized non-invasive diabetes screening program by means of the FINDRISC score comparing with the oral glucose tolerance test results. At least one third of the screened subjects is expected to present high-risk criteria. They will choose 1 out of 3 interventions to modify lifestyle: self-acting vs. individualized or group-based educative (6-hour, 3 or 4 sessions program). Participants' motivation will be periodically reinforced. Follow-up will be focused on diabetes incidence, cardiovascular risk (HearthScore, Regicor scores), lifestyle-quality of life (assessed by European peer-reviewed questionnaires) and cost-effectiveness analysis. First-year results includes: protocol, measurement tools and database available, screening concluded (n=2082) and European intervention manual on type 2 diabetes prevention started.
Detailed Description
Diabetes is one of the most devastating diseases because of its big impact on public health. Taking fast decisions and vigorous actions like the ones proposed by this European project (DE-PLAN) adapted to the Spanish and the Catalan actual situation (coordinated project FIS and DE-PLAN-CAT respectively) can avert it. We consider a two-step strategy whose main objective is the primary prevention of diabetes in the European population at highest-risk. At the first stage, a non-invasive screening program will evaluate the risk of diabetes by means of a validated questionnaire (FINDRISK survey). It will be distributed at random to 2000 outpatients of public health service in Catalonia. It involves twenty primary care facilities that refer to five different centers where research scientists (executive committee) are coordinated by the head of these centers (coordinating committee) and are organised (managing committee) according to the European regulation (central committee). One third of the subjects are expected to present high-risk criteria. They will choose one out of three possible interventions to modify their lifestyle (informative approach, one-to-one or group training). For the last options, a 6-hour training program will be carried out in four sessions lasting 1,5 hours each. The trainers in charge will periodically stimulate the participants motivation. The study will go on in the routine health care and it will assess diabetes incidence according to the economic estimation of the cost-effectiveness relation of the adopted measures involved in health care policies and prevention programs. This project aims to evidence how the already known efficacy of these types of programs can apply to its effectiveness (on large populations) and its cost-effectiveness (in socio-economic terms). Other objectives are 1) to create one bigger database of diabetes and cardiovascular disease risks and 2) to contribute to the edition of a European manual on type 2 diabetes prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Prevention, Diabetes mellitus, Lifestyle changes, Cardiovascular risk, Cost-effectiveness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2082 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Complete lifestyle counseling including Individual intervention, OR Group intervention
Arm Title
Usual health care
Arm Type
No Intervention
Arm Description
Usual health care, including self-administered information by leaflets
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
Other Intervention Name(s)
Individual intervention, Group intervention
Intervention Description
INDIVIDUAL INTERVENTIONS They were programmed to come the nurse office three times (1 ½ -2 hours each). Individual intervention efforts outside of weight control and other intervention groups were also supported. In fact, this kind of intervention was similar to the group intervention but one-by-one participant subject. GROUP INTERVENTIONS Six-hour educational programme structured in 2 to 4 sessions with 5 to 15 participants. We called all participants to remind them their group schedule (date/hour). The methods used in the group intervention were variable depending on the experience of the manager, group member' s needs and skills available (empowerment). Results were based on motivation, support from the other members, peer support and positive feedback.
Primary Outcome Measure Information:
Title
Incident cases of type 2 diabetes
Description
New cases of type 2 diabetes in subjects with high risk during the duration of the study
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Evaluation of quality of life
Description
Quality of life in the 15-D questionnaire
Time Frame
4 years
Title
Cost-effectiveness
Description
Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High risk (> or equal 14 points in FINDRISC score) PTOG with IFG/ITG or both Able to sign informed consent Exclusion Criteria: Type 2 diabetes in screening Low risk (< 14 points in FINDRISC) Terminal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardo Costa, MD PhD
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22322921
Citation
Costa B, Barrio F, Cabre JJ, Pinol JL, Cos X, Sole C, Bolibar B, Basora J, Castell C, Sola-Morales O, Salas-Salvado J, Lindstrom J, Tuomilehto J; DE-PLAN-CAT Research Group. Delaying progression to type 2 diabetes among high-risk Spanish individuals is feasible in real-life primary healthcare settings using intensive lifestyle intervention. Diabetologia. 2012 May;55(5):1319-28. doi: 10.1007/s00125-012-2492-6. Epub 2012 Feb 10.
Results Reference
derived

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Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia

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